Process Development Associate - Digital Tools, Solid Dosage

Amgen; Thousand Oaks (CA); Hybrid; USD 75.000 - 101.000; Vollzeit

Benefits dieser Stelle

Stock-based long-term incentives

Retirement plan

Medical, dental and vision coverage

Discretionary annual bonus program

Flexible work models (remote/hybrid)

Zusammenfassung

Amgen in Thousand Oaks, CA seeks a Process Development Associate to advance formulation and process work for solid dosage products. You will design digital tools to streamline workflows and support data-driven decisions within cross‑functional teams including analytical, R&D, and manufacturing.

The role requires a Master’s degree in a related field and experience with GMP processes, AI‑driven tools, and data analysis.

Qualifikationen

• Master’s degree (or foreign equivalent) in Bioengineering, Pharmaceutical Sciences, Chemical or Pharmaceutical Engineering, Chemistry, Life Sciences or a related field & completion of a university-level course, research project, internship, thesis, or one year of experience.
• Understanding of unit operations and formulation principles involved in the development and manufacture of oral solid dosage forms and related pharmaceutical processes.
• Proficiency in programming languages such as Python, R, and MATLAB, with experience in developing and enhancing AI-driven digital tools and user interfaces.
• Experience with GMP-compliant manufacturing operations under established SOPs to support clinical and commercial development programs.
• Experience introducing and integrating new digital modalities and visualization tools such as Figma, Power BI to improve user experience and data presentation, reducing manual data entry errors and streamlining cross-team data communication.
• Knowledge of image and statistical analysis tools including IMARIS, GraphPad Prism, and Excel to interpret experimental results and validate findings.
• Experience in market research, data analysis, statistical design and literature review to guide experimental design and support scientific publications; and
• Experience with ELN systems to accurately track experiments, improving data integrity and knowledge sharing across teams.

Aufgaben

• Research and provide hands on formulation and process expertise during the development of clinical and commercial products for solid oral dosage forms (small molecule focus).
• Design and develop specialized digital tools and applications for the synthetic drug products team to streamline experimental workflows to enable accurate and efficient calculation of critical parameters – directly supporting data driven decision making in process development.
• Collaborate across departments, including analytical, R&D, and manufacturing teams, to align project goals, resolve technical challenges, and ensure timely progress.
• Act as a liaison to integrate diverse expertise and maintain momentum on high priority-initiatives.
• Contribute to the drafting of scientific review papers and technical guideline documents by performing in-depth data analysis and experimental work.
• Support scientific content development through literature research, experimental validation, and cross functional collaboration to ensure scientific accuracy and practical relevance.
• Interface within the Drug Product Technologies and external functions as a team member to support programs and initiatives.
• Contribute to experimentation design and execution and assist in analysis and interpretation of data.
• Organize and communicate information within the team to help lead to the best possible formulation and processes for drug development.

Kenntnisse

Python

R

MATLAB

GMP operations

Figma

Power BI

Image analysis

GraphPad Prism

Excel

Market research

Data analysis

Statistical design

Literature review

ELN systems

Ausbildung

Master's degree in Bioengineering or related field

Tools

IMARIS

Jobbeschreibung

Amgen in Thousand Oaks, CA seeks a Process Development Associate to advance formulation and process work for solid dosage products. You will design digital tools to streamline workflows and support data-driven decisions within cross‑functional teams including analytical, R&D, and manufacturing.

The role requires a Master’s degree in a related field and experience with GMP processes, AI‑driven tools, and data analysis.